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Home Industry News GlaxoSmithKline reviews casopitant application

GlaxoSmithKline reviews casopitant application

25th June 2009

GlaxoSmithKline (GSK) is reviewing documents regarding the drug casopitant.

An application for the medication was originally submitted by the company to the Food and Drug Administration (FDA) on May 29th 2008.

The treatment is intended to prevent post-operative and chemotherapy-induced nausea and vomiting.

Earlier this week, the business received a complete response letter from the regulatory body about its proposal.

Such a document is issued by the FDA’s centre for drug evaluation and research department when an application has been reviewed but there are still some queries that need to be settled before it can be totally approved.

GSK stated it will look over the letter and engage with the regulatory body to determine what the most appropriate next step is.

Earlier this month, the company announced the FDA had extended the action date for the ofatumumab biologics license application by three months.

The decision about the drug will now be discussed on October 31st 2009.

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